|
|
26051 Merit Circle, Suite 104
Laguna Hills, CA 92653 USA
phone:(949) 215-3613
fax:
|
|
| Symbol |
Private |
| Founded |
2003 |
| Employees |
9 |
|
|
| www.lonestarheartinc.com/
|
|
| Research Sector |
Medical Devices & Tech |
|
 |
| Summary Description |
| Therapies to preserve and restore adequate heart function in patients with Congestive Heart Failure (CHF). |
|
| Management |
| Frank Ahmann, President & Chief Operating Officer;
Sam Helgerson, Ph.D., Chief Technology Officer;
Andy G. Hinson, Vice President, Clinical and Regulatory Affairs |
| |
|
|
| |
|
| Keywords |
| LoneStar Heart, Inc, CardioPolymers, Cardiology, Congestive Heart Failure, CHF, lone star heart |
|
|
|
| Description |
|
LoneStar Heart Inc. is a biomedical company developing new therapies for patients with Congestive Heart Failure (CHF), a condition that is becoming increasingly frequent in developed countries and which cost the US an estimate of $37.2B in 2009 alone. Current CHF therapy is based primarily on drug therapy that is palliative, but not curative. Cardiologists, electrophysiologists, heart surgeons, and basic scientists working with LoneStar Heart have made strides in areas such as the reprogramming of cells by switching gene combinations “on” and “off” and by identifying environments in which cardiac stem cells reside. Currently under clinical development for the treatment of CHF patients with enlarged left ventricles is Algisyl-LVR, a device which consists of an injectable proprietary biopolymer that thickens to form gel-like bodies that remain in the heart muscle as permanent implants that thicken, reshape, and realign as needed; product versions for cardiothoracic surgeons as well as for interventional cardiologists are both underway. This earlier-stage medical device and biotechnology company is also working in close collaboration with scientific teams at the University of Texas Southwestern Medical Center to validate a number of small molecule drugs that have the capacity to switch stem cell behavior into tissue-regenerative mode. |
|
| Products / Services |
Products are classified as medical devices and the Company's lead product, Algisyl-LVR, is designed to prevent or reverse the progression of chronic heart failure and mitral valve regurgitation, conditions affecting well over 5 million Americans.
|
|
| Technology / Differentiation |
| The Algisyl-LVR technology involves implanting a space-occupying biocompatible polymer into strategic areas of the heart's left ventricle (LV) wall to affect LV shape and prevent or reverse LV enlargement. Reshaping and thickening the LV wall reduces wall stress, improves pumping efficiency, reduces mitral valve regurgitation and provides lasting improvement of cardiac function. |
|
| Market / Customers |
The initial market for the product is $650 mill for use in NYHA Class III patients undergoing concomitant heart surgery with a target market of 300,000 patients in U.S. and W. Europe. The second generation of the product will greatly expand this market to $3 billion through the development of percutaneous approaches with a target market of 2,800,000 patients in U.S. and W. Europe.
|
|
| Status |
| Algisyl-LVR has been extensively tested in pre-clinical models for over two years to establish its mode of action, safety, efficacy and tolerability. Algisyl-LVR has advanced to human clinical studies with a Phase I study initiated in Munich, Germany in Q1 2009. The Phase II study is anticipated to begin in the first half of 2010. A percutanous approach to faciliate stand alone therapy is currently under development. |
|
|
|
|
|
|
|
Biotech & Specialty Pharma
Healthcare Services
Medical Devices & Tech
OneMedPlace Member
AdvaMed Members